1. Summary of Product Characteristics (SmPC)

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SmPCs are an integral part of the marketing authorisation of all medicines authorised in the European Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively. They are kept updated throughout the lifecycle of a medicine as new efficacy or safety data emerge.

SmPCs are also the basis for the preparation of package leaflets, and therefore are important documents in enabling information on medicines to reach patients.

As regards the legal background, the primary legislation is Directive 2001/83/EC which stipulates:

  • The application shall be accompanied by the following particulars and documents, submitted in accordance with Annex I:… A summary, in accordance with Article 11, of the product characteristics (Art. 8 (3)(j))
  • The summary of the product characteristics shall contain, in the order indicated below, the following information: [it follows the list of items to be included] (Art. 11)
  • ANNEX I Summary of Product Characteristics [NOTE: the following are those items of information required by Article 11 of Directive 2001/83/EC] Version 10.2 rev. 1, 02/2021 (see next).